BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS 2 IMMUNOASSAY SYSTEM

    MDR report key: 4111801 · Received September 23, 2014

    Report

    Report Number
    2122870-2014-00628
    Event Type
    Malfunction
    Date Received
    September 23, 2014
    Date of Event
    August 21, 2014
    Report Date
    August 25, 2014
    Manufacturer
    BECKMAN COULTER
    Product Code
    JJE
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER TROUBLESHOOTED THE INSTRUMENT WITH BECKMAN COULTER (BEC) CUSTOMER TECHNICAL SUPPORT (CTS). THE CUSTOMER FOUND LOOSE FITTINGS ON TOP OF THE SUBSTRATE CAP, WHICH CAN INTRODUCE AIR INTO THE SUBSTRATE FLUIDICS LINE. BEC FIELD SERVICE WAS DISPATCHED TO EVALUATE THE INSTRUMENT. THE FIELD SERVICE ENGINEER (FSE) FOUND BUBBLES IN THE SUBSTRATE FLUIDICS MODULE, WHICH WERE CLEARED AFTER PRIMING. A SYSTEM CHECK SUBSEQUENTLY PERFORMED PASSED. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED HUMAN CHORIONIC GONADOTROPIN (HCG5) CALIBRATION FAILURES ON AN ACCESS 2 IMMUNOASSAY SYSTEM. THERE WERE NO REPORTS OF ERRONEOUS RESULTS GENERATED OR IMPACT TO PATIENT TREATMENT IN CONNECTION WITH THIS EVENT. THE CALIBRATIONS FAILED FOR BAD FIT AND THE INVESTIGATOR NOTES IMPRECISION ON CALIBRATOR REPLICATES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    589770 ACCESS 2 IMMUNOASSAY SYSTEM ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE JJE BECKMAN COULTER NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1